System and method for digital remote primary, secondary, and tertiary color calibration via smart device in analysis of medical test results

ABSTRACT

A method for providing immunoassay test results includes collecting at least one biologic with a testing device, conjugating the biologic with particles on a conjugate pad of a test strip to create an immune complex, binding antigens or antibodies of the immune complex to antigens or antibodies of a test line, providing a software application to be stored on a mobile device having a camera; capturing an image of the testing device, including a color mosaic having at least one color value corresponding to a positive test result, comparing the color values of the test line image to the color values of the image of the color mosaic, determining if the color values of the image of the test line are within a predetermined range of the at least one color value of the image of the color mosaic corresponding to a positive test result; and presenting test results on the viewing screen.

TECHNICAL FIELD

The following disclosure is related to a system and method forinitiating a telemedicine conference in response to diagnostic testresults.

SUMMARY

A method for initiating a telemedicine conference on a mobile device isprovided. The method comprises receiving diagnostic test results inresponse to a diagnostic test, determining if the diagnostic testresults include a positive result, storing the diagnostic test resultson a server disposed on a network, presenting, if the diagnostic testresults are positive, a telemedicine initiation option on a screen ofthe mobile device, determining whether the telemedicine initiationoption is selected, sending the diagnostic test results from the serverto the telemedicine provider, sending additional medical historyinformation to the telemedicine provider, and initiating a telemedicineconference with the telemedicine provider.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding, reference is now made to thefollowing description taken in conjunction with the accompanyingDrawings in which:

FIG. 1 illustrates a diagrammatic representation of one embodiment of aimmunoassay test strip;

FIG. 2 illustrates a diagrammatic representation of one embodiment of animmunoassay test wherein an analyte is tested across a plurality of teststrips;

FIG. 3 illustrates a diagrammatic representation of one embodiment of atesting device;

FIG. 4 illustrates a top view of the testing device of FIG. 3;

FIG. 5 illustrates a top view of one embodiment of a testing device;

FIG. 6 illustrates a top view of another embodiment of a testing device;

FIG. 7 illustrates a flowchart of one embodiment of a testing device usemethod;

FIG. 8A illustrates a diagrammatic representation of one embodiment of aprocess for a mobile device application for testing device image captureand image processing, wherein an image alignment indicator is notaligned with the subject of the image;

FIG. 8B illustrates a diagrammatic representation of one embodiment of aprocess for a mobile device application for testing device image captureand image processing, wherein an image alignment indicator is alignedwith the subject of the image;

FIG. 9 illustrates a flowchart of one embodiment of an image analysisprocess using a mobile device;

FIG. 10 illustrates a diagrammatic representation of another embodimentof a process for a mobile device application for testing device imagecapture and image processing, wherein an image alignment indicator isaligned with the subject of the image;

FIG. 11 illustrates one embodiment of a consumer driven biologic anddisease data collection system;

FIG. 12 illustrates one embodiment of a consumer driven biologic anddisease data collection system;

FIG. 13 illustrates an example of a unique biologic ID database table;

FIG. 14 illustrates a flowchart of one embodiment of a biologic datacollection and dissemination process;

FIG. 15 illustrates a perspective view of a system for scanning teststrips;

FIG. 16 illustrates a cross-sectional view of the system of FIG. 15;

FIG. 17 illustrates one embodiment of a vertical flow immunoassaydevice;

FIG. 18 illustrates a cross-sectional view of one embodiment of thevertical immunoassay device of FIG. 17;

FIG. 19 illustrates a color gradient chart;

FIG. 20 illustrates a normalized past tests results rating chart;

FIG. 21 illustrates a mobile device displaying on a screen a mobileapplication variable test functionality;

FIG. 22 illustrates the mobile device of FIG. 21, wherein a housing of atesting device also includes thereon test function indicators;

FIG. 23 illustrates one embodiment of a medical code correlation system;

FIG. 24 illustrates one embodiment of a strep home retail test codestable;

FIG. 25 illustrates one embodiment of a combined pregnancy and Zika homeretail test codes table;

FIG. 26 illustrates a flowchart of one embodiment of a medical codecorrelation process;

FIG. 27 illustrates one embodiment of a telemedicine initiation optionwithin a mobile application;

FIG. 28 illustrates another embodiment of a telemedicine initiationoption within a mobile application;

FIG. 29 illustrates one embodiment of a telemedicine conference sessionon a mobile device;

FIG. 30 illustrates a flowchart of one embodiment of a medical filehandoff process;

FIG. 31 illustrates a flowchart of one embodiment of a telemedicineconference initiation process;

FIG. 32 illustrates a diagrammatic representation of one embodiment of aimmunoassay test strip incorporating a color mosaic;

FIG. 33 is a diagrammatic representation of a color mosaic;

FIG. 34 is a diagrammatic representation of one embodiment of a testingdevice;

FIG. 35 illustrates a diagrammatic representation of one embodiment of atesting device;

FIG. 36 illustrates a diagrammatic representation of one embodiment of aprocess for a mobile device application for testing device image captureand image processing;

FIG. 37 illustrates a flowchart one embodiment of an image analysisprocess using a mobile device with a camera;

FIG. 38 illustrates a diagrammatic representation of one embodiment of atesting device;

FIG. 39 illustrates a diagrammatic representation of one embodiment of aprocess for a mobile device application for testing device image captureand image processing; and

FIG. 40 illustrates a flowchart one embodiment of an image analysisprocess using a mobile device with a camera.

DETAILED DESCRIPTION

Referring now to the drawings, wherein like reference numbers are usedherein to designate like elements throughout, the various views andembodiments of an arbovirus indicative birth defect risk test areillustrated and described, and other possible embodiments are described.The figures are not necessarily drawn to scale, and in some instancesthe drawings have been exaggerated and/or simplified in places forillustrative purposes only. One of ordinary skill in the art willappreciate the many possible applications and variations based on thefollowing examples of possible embodiments.

Referring now to FIG. 1, there is illustrated one embodiment of animmunoassay test strip 100. The test strip 100 is typically housed in atesting device configured to collect a biologic analyte 106 from a userand to direct to the biologic analyte 106 onto the testing strip 100.However, it will be understood that the biologic may be applied onto astrip 100 without the strip 100 needing to be within a testing device.The test strip 100 includes a backing 102. The test strip 100 is made upof multiple sections disposed on the backing 102. A sample pad 104 isdisposed on one end of the strip 100, for collecting the biologicanalyte 106. The biologic analyte 106 may be any biologic needed for usein the immunoassay, such as urine, blood, saliva, stool, sweat, or otherbiologics to be used as an analyte. Various methods may be used toacquire the needed biologic, and such may be provided to the userpackaged with the test, such as swabs, vials, containers, dilutants andother solutions, or any other equipment required. In the case of a bloodanalyte, a few drops of blood may be obtained from a finger stick usinga finger prick device. Such a blood analyte may be blood mixed with anadequate amount of buffered solution to create the sample analyte 106 ora blood sample that is not diluted or otherwise manipulated, in whichcase the blood only is the analyte 106.

The biologic analyte 106, after coming into contact with the sample pad104, begins to migrate across the strip 100 by capillary action, cominginto contact with other sections of the strip 100. A particle conjugatepad 108 is disposed between the sample pad 104 and a test line 110. Theconjugate pad 108 may contain various reagents associated with aparticular antigen, such as a virus, allergen, or bacteria, the reagentsbeing items such antibodies, enzymes, or other reagents needed todiagnose the particular condition. The reagent in the conjugate pad 108may be conjugated with particles of materials such as colloid gold orcolored latex beads. As the analyte 106 migrates through the conjugatepad 108, antibodies present in the sample analyte 106 complex with thereagents in the conjugate pad 108, thereby creating an immune complexthat will migrate to the test zone or test line 110.

The test line 110 (T) may be precoated with the relevant antigen inquestion, i.e., a virus, allergen, or bacteria, for the detection ofantibodies associated with the particular antigen. The immune complexcreated when the analyte 106 passes through the conjugate pad 108 iscaptured onto the antigen contained on the test line 110. This maycreate a qualitative response on the strip where the test line 110 islocated, such as a colored response. In some embodiments, the test line110 may not be a line, but may be other shapes or symbols, such as aplus sign. If no antigen-anti-antigen complexes are present in theanalyte, no reaction occurs in the test line 110 and a qualitativeresponse will not occur.

After passing through the test line 110, the analyte migrates furtheralong the strip to reach a control line 112, where excessanti-antibody-colloidal gold or latex conjugates get bound. Aqualitative response may be shown at the control line 112, indicatingthat the sample has adequately migrated across the testing membrane orsubstrate as intended. It will be understood that the control line 112is not necessarily needed to perform the test, and may be eliminatedentirely, but the control line 112 does provide a comparative examplefor a user reading the test. For example, the control line 112, inembodiments where a colored qualitative response is provided, may appearas an overly saturated color, such as a dark or bright saturated red,once the sample reaches the control line 112. This saturated color maybe used as a comparison against the qualitative response shown on thetest line 110. For example, if the qualitative response shown on thetest line 110 is a much lighter red than that on the test line 110, itmay be that very little reaction occurred at the test line. Of course,if no response is shown at all at the test line 110, no reaction hasoccurred. If the qualitative response at the test line 110 is of asimilar saturation to the control line 112, a strong reaction isindicated.

The strip 100 may not be a continuous substrate. Rather, the varioussections of the strip 100 may be separate from each other, but alladhered to the backing 102. As shown in FIG. 1, the sample pad 104 andthe conjugate pad 108 are separate structures from each other. The testline 100 or zone and the control line 112 or zone are both disposed aspart of a nitrocellulose membrane strip 114. The nitrocellulose membranestrip 114 is also adhered to the backing 102, but separate from thesample pad 104 and the conjugate pad 106. As shown in FIG. 1, the end ofthe sample pad 104 adjacent to the conjugate pad 106 may overlap theconjugate pad 106, with that end of the sample pad 106 lying over theadjacent end of the conjugate pad 106. Similarly, the end of theconjugate pad adjacent to the nitrocellulose membrane strip 114 may lieover the end of the nitrocellulose membrane adjacent to the conjugatepad. This allows for the analyte 106 to be more easily deposited ontoeach section of the strip 100 as it migrates across the strip 100. Afterthe analyte 106 migrates across the nitrocellulose membrane strip 114,and thus across the test line 110 and the control line 112, the analyte106 comes into contact with a wick 116 for absorption and collection ofthe analyte 106. The end of the wick 116 adjacent to the nitrocellulosemembrane strip 114 may lie over that adjacent end of the nitrocellulosemembrane strip 114, as shown in FIG. 1.

Several Flow Immune Assays have been directed toward identifyingproteins, molecules of interest, and even immunoglobulins IgG, IgA, andIgM. IgE is an antibody (immunoglobulin E) that is normally present inthe blood freely circulating until it moves into the tissue where it isbound to mast cells through the receptor FcERI (F-C-epsilon-R-one)otherwise known as the high affinity IgE receptor. There is a smallamount of IgE bound to IgE receptors (high and low affinity receptors)on basophils, eosinophils, and other cells in the blood and tissues.

Many assay systems are geared toward the detection of infectiousproteins. All of the aforementioned tests use a non-humanantibody—usually IgG type—e.g., goat IgG antibody directed against aprotein of interest to detect the protein of interest from the sample(blood, urine, saliva, sweat, etc.). This antibody complexes withprotein of interest and forms a complex that travels across the membraneuntil it reaches the test zone. In the test zone there is an IgG typeantibody directed against IgG from that species of animal. As furtherdescribed herein, the present detecting apparatus and method use human(patient/consumer-derived) antibodies from the sample and the test zonethat contains a humanized antibody directed against the protein ofinterest that is preconjugated to a detecting substance that results ina visual change.

Summary of Target Antigen:

-   -   The target antigens may be proteins, glycoproteins, lipoproteins        or other molecular substances capable of eliciting an immune        reaction and/or being bound by human specific IgE (sIgE).

Immune Assay to Detect Specific IgE:

-   -   In the detecting apparatus and method of using the same, the        antigens are proteins conjugated to a noble metal, for example,        gold, or latex conjugated to antigen in the test zone, for the        purpose of detecting the presence of specific IgE (e.g.,        anti-peanut IgE in a blood sample from a finger prick). For        example, an IgG class antibody (IgG1, IgG2, IgG3, or IgG4) or        fragments of those classes of antibodies (fab fragments) whose        origin may be any animal species (goat, rat, human, etc.)        capable of detecting human IgE (anti-IgE IgG)—a suitable        commercially available humanized antibody, such as omaluzimab        may be used—may be used to form immune complexes of        IgG-anti-IgE-sIgE that will migrate to the test zone having        selected specific IgE that can bind to the conjugated antigen.

Immune Assay to Detect Total IgE (not Concerned about Specific IgE):

-   -   Another embodiment includes using an IgG class antibody (IgG1,        IgG2, IgG3, or IgG4) or fragments of those classes of antibodies        (fab fragments) whose origin may be any animal species (goat,        rat, human, etc.) capable of detecting human IgE (anti-IgE        IgG)—a suitable commercially available humanized antibody that        is preconjugated to a detecting molecule that results in a color        change when bound to IgE as the target antigen in the test zone.

Referring now to FIG. 2, there is illustrated one embodiment of animmunoassay test 200 wherein an analyte 202 is tested across a pluralityof test strips 204. The plurality of test strips 204 may each beconfigured for testing for a particular antigen. For instance, one stripmay be for testing for the presence of streptococcal bacteria (strepthroat), one strip may be for testing for a peanut allergy, one stripmay be for testing for the Zika virus, etc. Additionally, each strip mayalso test for multiple antigens. For example, as shown in FIG. 2,multiple testing panels or lines maybe be incorporated. Each line may befor a particular antigen. As shown in FIG. 2, multiple test lines 206,208, and 208 may be disposed along the plurality of strips 204. A striptesting for allergens may have a panel for testing for peanut allergiesshown at test line 206 (CH1), for cat allergies shown at test line 208(CH2), or grass allergies shown at test line 210 (CH3).

Other examples of configurations for the testing panels can be, but arenot limited to: 1) Food 5: Peanut, milk, soy, wheat, egg; 2) Nut andseed panel: almond, cashew, hazelnut, peanut, pecan, walnut, sesameseed, sunflower seed; 3) seafood: crab, lobster, shrimp, salmon, tuna;4) Pets: cat, dog; 5) Indoor allergens: dust mites, mold mix(alternaria, aspergillus, penicillium, cladosporium), cat, dog; and 6)seasonal allergens: grass (Bermuda, bahia, Johnson, rye, timothy), trees(oak, elm, cedar, mesquite, pine, etc.), weeds (pigweed, ragweed, sage,Russian thistle).

With respect to other non-allergen antigens, the panels may be fortesting for strep, Zika, flu, anthrax, cold viruses, cancer, HPV, Lymedisease, mononucleosis (mono), and other illnesses, and/or otherconditions such as pregnancy (hCG detection) and disease risks. Someembodiments may allow for the testing of various arboviruses(arthropod-borne viruses). Arboviruses are viruses that are transmittedby arthropods, with mosquitoes being a common vector for the virus.Vectors are organisms that transfer the virus from a host that carriesthe virus. Thus, in the case of mosquitoes, a mosquito that feeds on ahost that is infected with a virus may infect others when that mosquitoagain feeds on an uninfected host. Well-known arboviruses include Denguevirus, Japanese encephalitis virus, Rift Valley fever virus, West Nilevirus, yellow fever virus, chikungunya, and Zika virus. Urine, blood,and saliva and other biologics may be used for arboviruses testing.

Certain antigens or medical conditions may be logically paired together.For instance, a testing device may include both a strip for detection ofpregnancy and a strip for the detection of the Zika virus, as the Zikavirus has been known to cause birth defects in infants born to pregnantwomen that are infected with Zika. Thus, combining these two tests intoa single testing device or kit would alert a woman to a potential Zikainfection proximate in time to the time she also discovers she ispregnant, allowing the woman to seek medical attention immediately. Thisis a substantial improvement over past Zika testing, where a woman maybe required to wait weeks before results are returned from a lab afterhaving the biologic collected by her physician. In many cases, this maylead to a woman having passed a state-mandated cutoff point forabortions, such as 24 weeks in some states. Combining a Zika test with apregnancy test and physically linking the two tests, and thus allowingfor a woman to determine a Zika risk at the time of taking a pregnancytest, in which a pregnancy test may be taken as soon as six days afterconception, allows for that woman to take action much sooner than thestate mandated cutoff and waiting for lab results would allow.

Various testing devices that include the test strip 100 or strips may beused, such as a slide that supports the test strip 100, a cassette baseddiagnostic test, a dipstick, or combinations thereof. The test resultsin various embodiments may be in the form of a visual qualitativereading test, a visual semiquantitative format, a reader quantitativeassay format, and/or combinations thereof. Additionally, an electronicimplementation may be used where the result is displayed digitally on ascreen disposed within the apparatus, and visible to the user.

The apparatus and method of detection may be a “one-step” approach fromsample to reading without sample dilution or other sample manipulation.The sample may be diluted or endure other sample manipulation, forexample the blood sample is diluted with a buffer.

Referring now to FIG. 3, there is illustrated a diagrammaticrepresentation of one embodiment of a testing device 300. The testingdevice 300 includes a housing 302 that forms the body of the testingdevice. The housing 302 may be made of plastic, metal, or any materialdurable enough for shipping and subsequent handling by a user. Thehousing 302 may be hollow so that a plurality of test strips 304 may behoused within and so that a biologic may be deposited within the housing302. The testing device 300 may further have a plurality of windows 306,each window being associated with one of the plurality of test strips304, and allowing for a user to view at least the section of thenitrocellulose membrane strip 114 where the test line 110 and controlline 112 are located. The plurality of windows 306 may be open, orcovered with plastic, glass, or other materials that allow for viewingthe plurality of strips 304. A sample well 308 may be disposed on asurface of the housing 302 to allow a user to deposit a biologic intothe housing 302. The sample well 308 would be disposed over or near thesample pad 104 of the test strip or strips 100. In the embodiment shownin FIG. 3, a single sample well 308 is included for collection of asingle type of biologic for testing, with each of the plurality ofstrips 304 being suited for testing for antigens using that particularbiologic sample type. For example, if the testing device 300 is acombined pregnancy and Zika test, having both a pregnancy strip and aZika strip, a urine sample may be deposited into the sample well 308,causing the urine sample to come into contact with the sample pad 104 onboth the pregnancy strip and the Zika strip. It will be understood thatboth of these tests may also be performed with a blood sample.

The testing device 300 may also have disposed on the surface of thehousing a crosshair symbol 310, used as an alignment target. This symbolmay be a graphic printed or adhered to the testing device 300. Thecrosshair symbol 310 is used to align the testing device 300 for thetaking of an image of the testing device 300 using a camera on a mobiledevice, for use in a mobile device application described herein. Inother embodiments, the crosshair symbol 310 may be other types ofsymbols, such as a simple shape (circle, square, etc.), other images(such as a medical cross symbol, an arrow, etc.), or any other type ofimage.

Referring now to FIG. 4, there is illustrated a top view of the testingdevice 300. There is again shown the housing 302, the plurality of teststrips 304, the plurality of windows 306, the sample well 308, and thecrosshair symbol 310.

Referring now to FIG. 5, there is illustrated a top view of oneembodiment of a testing device 500. The testing device 500 includes ahousing 502 having a plurality of test strips 504 within the housing 502and a plurality of windows 506 for display of the plurality of strips504. The housing 502 also includes a plurality of sample wells 508disposed on one side of the testing device 500. Each of the plurality ofsample wells 508 is associated with one of the plurality of test strips504 and each of the plurality of sample wells 508 may be disposed overone of the sample pads 104 on the associated one of the plurality oftest strips 504. This allows for a biologic to be deposited into each ofthe plurality of sample wells 508, with each well 508 serving totransfer the biologic to the test strip underneath the sample well. Thetesting device 500 further includes a crosshair 510. The crosshairsymbol 510 is used to align the testing device 500 for the taking of animage of the testing device 500 using a camera on a mobile device, foruse in a mobile device application described herein.

Referring now to FIG. 6, there is illustrated a top view of anotherembodiment of a testing device 600. The testing device 600 includes ahousing 602 having a plurality of test strips 604 within the housing 602and a plurality of windows 606 for display of the plurality of strips604. The housing 602 also includes a plurality of sample wells 608. Inthis embodiment, the sample wells are located on different ends of thehousing 602. In the case of a two test strip device, the sample wells608 are disposed on opposite ends of the testing device 600. The strips604 would be arranged within the housing in such a way as to allow thesample pad 104 on each of the strip to be disposed underneath one of thesample wells 608. This is useful for testing devices that requiredifferent biological samples. For example, if the testing device 600required a urine sample for one strip and a blood sample for the otherstrip, having the wells 608 disposed on opposite sides of the testingdevice would reduce the likelihood that a urine sample, for instance,might be inadvertently deposited into the well designated for the bloodsample. In embodiments where there are more than two strips, and morethan two wells, the well positions may alternate between the two sidesof the testing device. For instance, a first well for a first stripmight be disposed on the left side of the testing device, a second wellfor a second strip might be disposed on the right side of the testingdevice, a third well for a third strip might be disposed on the leftside of the testing device, a fourth well for a fourth strip might bedisposed on the right side of the testing device, and so on. The testingdevice 600 further includes a crosshair 610. The crosshair symbol 610 isused to align the testing device 600 for the taking of an image of thetesting device 600 using a camera on a mobile device, for use in amobile device application described herein.

The diagnostic test can, for example, be produced in a various formatsfor different users, such as, but not limited to, consumer/in-home usewhere the test is purchased through retail channels which will allowindividuals to get an immediate, cost-effective test result that canlead to specific avoidance and treatment through follow-up with amedical professional.

The diagnostic test can be provided to and used by hospitals and clinicsto provide rapid, on-site test results that are required to prescribecertain medications, such as omaluzimab, by their FDA labels.

This diagnostic assay can be modified to detect the presence of specificIgE in pets.

It is also noted that housing 602 is designed such that both strips 604are disposed in physical proximity thereto and in the same actualhousing. In this manner, both sets are linked physically to each othersuch that they cannot be separated and can be associated with a singleindividual and the actual test cannot be separated. As such, when apatient applies the specimens to the two areas 608 and the test resultsare exhibited, there is a high probability that two tests were performedat the same time associated with the same patient. Additionally, andelectronic chip (not shown) can be embedded within the housing 602 suchthat the housing 602 can be registered to a specific patient andassociated with the medical records of that patient.

Referring now to FIG. 7, there is illustrated a flowchart of oneembodiment of a testing device use method 700. The method 700 begins atstep 702 where a biologic is collected in a sample well or wells of atesting device. The biologic collected may be a non-diluted ornon-manipulated biologic, such as blood, urine, or saliva from the userof the test. Diluted or manipulated biologics may be used instead, asrequired by the specific test. For example, if a viral test requires thebiologic to be added to a solution, the biologic could be added to asolution that has previously been placed in a sterilized vial providedwith the testing device. After the required amount of time has passed,the solution containing the biologic could be deposited into the well orwells. At step 704, the biologic contacts a sample pad disposed on astrip or strips within the testing device. At step 706, the biologicmigrates along the strip or strips to come into contact with a conjugatepad containing antibodies. Antibodies present in the biologic willcomplex with the antibodies in the conjugate pad to create an immunecomplex. At step 708, the biologic migrates into a test zone of thestrip or strips, coming into contact with an antigen. The antibodies inthe conjugate pad serve to provide a means of detection, such as acolored response, if the immune complex binds with the antigen presentin the test zone of the strip. At decision block 710, binding of theantibodies with the antigen may or may not occur depending on ifantibodies associated with the antigen are present in the biologic ornot. If a binding between the antibodies and the antigen does not occurthe process moves to step 712 where no qualitative response is producedon the test line. If a binding does occur, at step 714 a qualitativeresponse is produced on the test line. Whether a binding occurs or not,and whether a qualitative response is produced or not, the process movesto step 716 where the biologic migrates into a control zone of the stripor strips where excess conjugates get bound and produces a qualitativecontrol zone reaction indicating that the sample has adequately migratedacross the testing zone.

It will be understood by one skilled in the art that the antibodies andantigens applied to the testing strip may be altered depending on thetype of condition being tested. For example, in the case of testing formedical conditions that do not involve an illness or infection, likepregnancy, and thus the sample biologic does not contain antibodiesassociated with the condition, antibodies that react to markers beingtested for may be applied to the testing strip instead of an antigen.For instance, pregnancy test requires testing for the presence of hCG.Since hCG is a hormone and not an antibody produced in response to aninfection, the testing strip may have antibodies that will react to thepresence of hCG applied to the testing zone or line of the testingstrip, as well as to the conjugate pad. Similarly, some tests mightrequire antibodies be applied to the testing strip to detect antigenspresent in the sample, rather than antibodies.

Referring now to FIGS. 8A and 8B, there is illustrated a diagrammaticview of one embodiment of a process 800 for a mobile device applicationfor testing device image capture and image processing. The mobile deviceapplication allows for an image of a testing device, such as testingdevice 300, to be captured using a camera installed on a mobile device802 having a screen 804. While the mobile device 802 displays on thescreen 804 the scene captured by the camera, the mobile deviceapplication also displays a graphic on the screen 804 in the form of aboxed outline 806, the size of the outline 806 corresponding to the sizeof the testing device 300. Also displayed on the screen of the mobiledevice 802 within or near the outline is a crosshair graphic 808. A userof the mobile device 802 attempts to align the outline 806 with theborders of the testing device 300 and also attempts to align thecrosshair graphic 808 with the crosshair 310 on the testing device 300.While alignment has not yet been achieved, a misalignment warning 810may appear on the screen of the mobile device 802, indicating to theuser that alignment has not yet been achieved. Such is shown in FIG. 8A.

In FIG. 8B, there is shown the result of a successful alignment of theoutline 806 with the testing device 300 and successful alignment of thecrosshair graphic 808 with the crosshair 310 on the testing device 300.As shown in FIG. 8B, once aligned, a success indicator 812 may appear,such as a check mark or other positive status symbol, on the alignedimage. Successful alignment causes the camera on the mobile device 802to capture the current image of the testing device 300. Other checks mayoccur, including ensuring that the image is focused before the image issaved. This image is then processed to determine a result based on theseverity of the reaction occurring on the test strip. The mobile deviceapplication performs an analysis of the test line captured in the image,counting the number of colored pixels, as well as determining theintensity of the color. The mobile device may then compare this numberand color intensity to that in the control line, providing amathematical evaluation of the test line. Utilizing unique wavelengthsof light for illumination in conjunction with either CMOS or CCDdetection technology, a signal rich image is produced of the test linesto detect the colloid gold or latex particles. This provides anadvantage because a user simply looking at the two lines may not knowwhat the test line indicates, such as when the colored line does appearson the strip, but it is a faded line, rather than a dark line. Based onthis analysis, the mobile device application may provide a resultsindicator 814.

The results indicator 814 may be a qualitative result or a quantitativeresult. For example, and as shown in FIG. 8B, a qualitative result forthe results indicator 814 may indicate, in the case of a testing devicefor testing pregnancy as well as an infection, a plus sign next to aline reading “pregnant:” and a plus sign next to a line reading“infection:” to indicate that the user is both pregnant and infectedwith the bacteria or virus being tested, such as the Zika virus. For aquantitative result, the results might provide a numeric rating. Forinstance, a rating system between 1-100 may be used. If the resultsprovide a low rating to the user, such as a rating of 10, this indicatesa low risk of infection, although medical attention may be sought by theuser anyway. For example, if the user is pregnant, and also receives a10 rating for Zika, this may indicate that Zika was detected in lowamounts. However, the user may still seek medical attention or furthertesting from her doctor because Zika has been known to cause birthdefects. If the rating is a high rating, such as 95, this indicates thatan infection has most likely occurred and medical attention should besought immediately.

This same quantitative rating system may be applied to any test (viralinfections, bacterial infections, pregnancy, and other healthconditions), as the quantitative test can be performed using thesoftware described herein to accurately test bound antibodyconcentrations on the test strip. In some embodiments, a combinedqualitative and quantitative result may be presented, such as both arating and a plus or minus sign being presented, or other types ofquantitative and qualitative indications. Additionally, variouscombinations of tests may be provided for in the testing device, such aspregnancy/Zika, pregnancy/flu, pregnancy/strep/Zika, etc.

Referring now to FIG. 9, there is illustrated a flowchart of oneembodiment of an image analysis process 900 using a mobile device. Atstep 902 a mobile device application is launched. At step 904 a cameraon the mobile device is activated and a crosshair indicator and atesting device outline appear on the mobile device screen. At step 906the crosshair indicator presented on the screen of the mobile device isaligned with a crosshair icon on the testing device and the deviceoutline presented on the screen of the mobile device is aligned with theborders of a testing device. At step 908, an indicator of successfulalignment is presented on the screen and an image of the testing deviceis taken by the mobile device camera. At step 910, the mobile deviceapplication processes the image of the testing device to determine testline strength by counting the number of colored pixels contained in thetest line. At step 912, the mobile device application correlates lineintensity with analyte concentrations to further determine test linestrength. At step 914, the mobile device application presents the testresults based on pixel count and line intensity, providing either aqualitative or quantitative result.

In some embodiments, the number of pixels indicating bound antibodies onthe strip may be measured against that in the control line to compareline intensity between the two lines, with the control line acting as anexample of a strong reaction, indicating a strong infection, anddetermining how close the test line intensity is to the control line.This would lead to a logical quantitative result. For instance, if thetest line is determined to have a pixel count and line intensity that is25% of the pixel count and line intensity of the control line, a ratingof 25 may be given. If a qualitative result is to be provided, a ratingof 25 may give a qualitative result that is negative, or it could bepositive depending on the type of condition being tested and knownactual infection results where a rating of 25 occurred for thatcondition.

In some embodiments, the test line may not be compared with the controlline to determine a result. Rather, the mobile device application mayhave access to a database having data on numerous past tests for thesame condition. This data may instead be used as the control. Thisallows the application on the mobile device to retrieve data on pasttests and compare the test line data of the current test to past tests.Overall data for past tests may be provided and compared against, suchas providing an average or a curve of past tests, or individual testsrated as having accurate results may be compared against.

In addition to a status result of an infection or other medicalcondition being provided to the user, other indicators of health mayalso be tested and results thereon provided. This provides for potentialearly identification of pregnancy and risk of morbidity, allowing formedical attention to be sought much more quickly. Indicators of healthmay be detected from biologics, such as urine and blood. Urine, forexample, allows for the detection of glucose levels, proteins, bacteria,and infectious markers. In the case of glucose, glucose is usually notfound in urine, but, if it is, that is an indicator of extremely highlevels of glucose in the body, where the kidneys release excess glucoseinto urine. This is often a sign of diabetes. Protein in the urine mayindicate a malfunctioning of the kidneys, which could be the result ofhigh blood pressure. Similarly, if blood is detected in urine, it couldbe a sign of a problem with the kidneys or the bladder. Blood, forexample, allows for the detection of glucose, inflammation, hormones,genetic defect risks, and metabolic endocrine disorders.

Referring now to FIG. 10, there is illustrated another embodiment of asuccessful alignment of the outline 806 with the testing device 300 andsuccessful alignment of the crosshair graphic 808 with the crosshair 310on the testing device 300, wherein quantitative results for health riskindicators are provided. In this embodiment, the results indicator 814provides a qualitative result for pregnancy and quantitative results forother health risk indicators. In the embodiment shown in FIG. 10, thehealth risk indicators being tested are markers for blood pressure andfor glucose levels. For blood pressure, this is a test for markers inthe blood that can be associated with high blood pressure. These couldbe test for such things as low levels of vitamin D and the such. Studieshave shown that patients suffering from essential hypertension will beunder oxidative stress and Malondialdehyde (MDA) is the principal andmost studied product of polyunsaturated fatty acid pre-oxidation. Thiscan show an indirect correlation with anti-oxidants, particularly withsuperoxide dismutases (SODs) (r=0.573) and catalase (r=0.633)representative anti-oxidant are involved in reducing the stress of apatient's biological system during hypertension. Another marker forhypertension is buildup of uric acid, where in uric acid is a marker forxanthine oxidase-associated oxidants and that the latter could bedriving the hypertensive response. Additional markers are cortisol, ahormone. The test strips 604 can test for the different biologicalmarkers.

The results indicator 814 provides numeric ratings, in this case, 1-100,with the blood pressure rating being 88 and the glucose rating being 95.This indicates that both blood pressure and glucose are extremely high.Due to this, an additional alert indicator 1002 is presented to the useron the screen of the mobile device, alerting the user to seek medicalattention immediately. This is to ensure that the health of both thepregnant woman and the fetus can be checked as close to the time ofpregnancy detection as possible and medical attention received ifneeded.

Referring now to FIG. 11, there is provided a flowchart of oneembodiment of a pregnancy disease risk assessment process 1100. Theprocess 1100 begins at step 1102 where a biologic is collected anddeposited in a testing device for testing of the biologic. At step 1104,the biologic is processed by the testing device for detection ofpregnancy and various other medical conditions. These medical conditionsmay be high blood pressure, diabetes, bacterial or viral infections,inflammation, an increase in hormone levels, genetic disease markers,and/or metabolic disorders. At step 1106, a mobile device is used tocapture an image of the testing device after testing is complete. Insome embodiments, test results may be immediate. In other embodiments,and depending on the medical conditions being tested, the test may takea certain amount of time to complete. In this case, the user of the testwould be alerted to this fact in instructions provided with the testingdevice. Additionally, a visual indicator on the testing device may alertthe user that a test is now complete. At step 1108, the mobile deviceprovides a rating for each medical condition being tested, such as thatdescribed with respect to FIG. 10 herein.

At decision block 1110, it is determined whether the ratings for eachcondition exceed a certain threshold for that condition. If not, theprocess 1100 moves to step 1112, where an indication is presented to theuser via the mobile device screen that medical attention is notcurrently advised or necessary. If at step 1110 it is determined that atleast one of the medical conditions being tested rises above a certainthreshold, the process 1100 moves to step 1114 where a warning ispresented to the user via the mobile device screen that medicalattention is advised. The thresholds for medical conditions may nottrigger a warning even if a rating exceeds a threshold, if, in the eventof multiple tests being performed, the combined test results do notwarrant immediate medical attention. For example, if a user is testingfor a cold virus, blood pressure, and glucose, and only the cold virusrating is above the threshold, there may not be a warning provided tothe user. Additionally, ratings may be weighted or aggregated based onthe medical conditions being tested. For example, if blood pressure,inflammation, and glucose are being tested for, and they all are givenonly moderate ratings that do not rise above the threshold for anycondition individually, an warning to seek medical attention may stillbe provided due to the combination of conditions taken together.

Referring now to FIG. 12, there is illustrated one embodiment of aconsumer driven biologic and disease data collection system 1200. Datacollected from users performing the tests disclosed herein effectivelycan provide a wealth of information. As tests are performed data may bepassed by a plurality of mobile devices 1202 being used by usersperforming tests to a database 1204, the database being at a remoteserver 1206, over a network 1208. The user is sourcing a biologic fromuser's own body. This is done at home, not in a lab, hospital, orclinic. Each particular test would expect a certain type of biologic tobe provided. For instance, for a pregnancy test, a urine sample isprovided and tested for pregnancy markers. For a stool test, the stoolmight be dissolved in a vial with a solution provided with the testingdevice/kit, and tested for various disease or infectious markers. Dataand results from the tests may be stored on the database 1204 at theremote server 1206. As described herein, this data may be used as acontrol for testing analysis for users of the plurality of mobiledevices 1202. This data may also be used to provide data sets forbiologics to a medical organization 1210. The medical organization 1210may be doctor's offices, researchers, hospitals, testing labs, and otherindividuals or organizations that have an interest in the health andanalysis of users taking the test and of their biologic samples. In thisway, data can be gathered from a variety of biologics tested for avariety of different medical conditions and characteristics.

Referring now to FIG. 13, there is illustrated an example of a uniquebiologic ID database table 1300. The table 1300 is illustrative of thetype of data stored in association with data for a biologic transmittedby the plurality of mobile devices 1202 for storage on the database1204. A biologic ID header 1302 is provided that shows that the biologicsample has been given a unique ID. All data concerning the biologic maybe stored in association with the unique biologic ID. The table 1300also includes a biologic type entry 1304. This designates what type ofbiologic that the biologic associated with the unique ID is, such asblood, urine, stool, saliva, sweat, or other biologics. The table 1300also provides a plurality of test ratings 1304, for various testsperformed on the biologic. In the example shown in FIG. 13, a bloodbiologic is provided having an assigned ID of 2402, and having beentesting for pregnancy markers, the Zika virus, and for glucose levels.The rating for pregnancy was a 99 rating, the rating for a Zikainfection was a 75, and the rating for glucose levels was a 10. Thiswould indicate that the test subject has an extremely high likelihood ofboth a pregnancy and a Zika infection, which would have resulted in awarning to seek medical attention at the conclusion of the tests. Otherinformation may also be stored in the database in relation to thebiologic, including other condition ratings, time and date each test wasperformed, user information such as ethnicity, gender, and age, andstatus indicators such as whether a test subject visited a physician asa result of the tests. The database 1204 thus provides the test subjectwith a growing collection of information that may be accessed by thetest subject. This allows the test subject to present the test resultsto her physician for medical attention or additional testing, and allowsfor others who may access the database, such as disease researchers, tohave access to data on various biologic samples and their markers.

Referring now to FIG. 14, there is illustrated a flowchart of oneembodiment of a biologic data collection and dissemination process 1400.The process 1400 begins at step 1402 where a user of a testing devicecollects a biologic sample for use in a test or a series of tests. Atstep 1404, the test or series of tests are performed on the biologicsample. At step 1406, a mobile device application checks the biologicsample the testing device result to determine a quantitative result ofthe test to provide a correlative value for the condition being testedin the biologic sample. At step 1408, the test results and correlativevalues, or multiple values if multiple tests on the biologic sample wereconducted, are transmitted to the remote server 1206. At step 1410, thebiologic sample is given a unique identification number in the database1204. At step 1412, the test results and correlative value or values arestored in the database 1204 in association with the uniqueidentification number given to the biologic sample collected and inassociation with the particular tests performed. This way, theparticular biologic sample may have various characteristics stored andretrieved in association with the biologic sample, and the test resultsmay also be retrieved when data on a particular test is needed on across-section of users.

At step 1414, the results are provided to the user on the user's mobiledevice. At step 1416, the results are provided to the user's healthcareprovider. The healthcare provider may receive the test results due to avisit from the user, the user bringing the results of the test with heron her mobile device, or the healthcare provider may receive the resultsfrom the database 1204 if the healthcare provider has permission toaccess the database 1204, or if access is granted in anticipation of theuser's appointment with the healthcare provider. At step 1418, the testresults are also provided to other healthcare industry individuals andorganizations, including medical researchers, hospitals, and others.

Referring now to FIG. 15, there is illustrated a perspective view of asystem for scanning test strips. The housing 604, as describedhereinabove with respect to FIG. 6, is illustrated as being disposedwithin a slot 1502 in a test housing 1504. The test housing 1504 isconnected through a line 1506 to a PC 1508. When the housing 604containing the test strips 604 after being subjected to the biologics isinserted within the slot 1502, the test housing 1504 will scan the teststrips 604 and analyze the results with the PC 1508. The PC 1508 willrun some type of algorithm that can analyze the results of both of thetest strips 604. There can be provided to indicators 1510 and 1512 onthe surface of the test housing 1504, one being, for example, a readyLED and one being a green LED. The PC 1508, after analyzing results, canthen provide a warning indicator such as lighting up the green LED for apositive indication of pregnancy and the red LED for indicating thatthere is some issue. As an example, suppose that the second test striptested for the Zika virus. If so, a warning would be appropriate tooutput and activate the red LED. There could be any other type ofindicator associated with the second test at 604 that, in a combinationwith the test results of the first test strip, i.e. for testing for thepresence of a pregnancy state, testing for such things as diabetes, etc.Further, although only two test strips 604 are illustrated, there couldbe multiple test strips testing for many different biological issuesthat may be present in an individual. In this embodiment, by insertingthe housing 602 into the test housing 1504 and allowing the PC 1508 toanalyze the results, the indicators associated with the test strips canbe analyzed with the assumption that all of the test return results wereassociated with an individual and in proximate time to each other. Thatmeans that the individual patient applied biological specimens, such asurine, blood, etc., to the appropriate test strips and, since these wereall contained within the same test strip housing 602, this provides anindication that they are associated with a single patient. Further, thetest performed will typically be a test that will provide a veryshort-term response. Thus, the specimens can be applied to the teststrips 604 in the test strip housing 602 and then inserted within theslot 1502 for testing by the PC 1508.

Referring now to FIG. 16, there is illustrated a cross-section of thetest housing 1504. It can be seen that the test strip housing 1602 ispassed in slot 1502 past the camera 1602. The camera 1602 is operable toscan a small cross-section of the test strips 604 on the surface thereofas the test strip housing 602 passes thereby. Of course, there couldalso be a much larger camera provided for taking an entire image of thetest strips 604 after being inserted within the test housing 1504. Thecamera 1602 is connected via a wire 1604 two in electronics package 1606to process the information and send it to the PC 1508. The electronicspackage 1606 will also drive the indicators 1510 and 1512.

Referring now to FIG. 17, there is illustrated one embodiment of avertical flow immunoassay device 1700. It will be understood thattesting device 300 and other embodiments herein illustrate a lateralflow immunoassay device. However, other types of immunoassay devices maybe used. For example, vertical flow immunoassay devices may be used, atwo-sided flow through assay, or even a sandwich ELISA test may be run.

The testing device 1700 includes a housing 1702 that forms the body ofthe testing device. The housing 1702 may be made of plastic, metal, orany material durable enough for shipping and subsequent handling by auser. The housing 1702 may be hollow so that a plurality of immunoassaytest pads 1704 may be housed within and so that a biologic may bedeposited within the housing 1702. The testing device 1700 may furtherhave a plurality of sample wells 1706, each sample well having one ofthe plurality of immunoassay test pads 1704 disposed within, andallowing for a user to view at least a section of a nitrocellulosemembrane of each of the immunoassay test pads 1704, the membrane 1708having a test line 1708 and control line 1710. The testing device 1700may also have disposed on the surface of the housing a crosshair symbol1712, used as an alignment target. This symbol may be a graphic printedor adhered to the testing device 1700. The crosshair symbol 1712 is usedto align the testing device 1700 for the taking of an image of thetesting device 1700 using a camera on a mobile device, for use in amobile device application described herein. In other embodiments, thecrosshair symbol 1712 may be other types of symbols, such as a simpleshape (circle, square, etc.), other images (such as a medical crosssymbol, an arrow, etc.), or any other type of image. In otherembodiments, the device 1700 may be configured in such a way as to allowa biologic sample to be deposited into a sample well, and to present theresults of the test on the opposite side of the housing. Such aconfiguration would allow the biologic to flow through the testing padwithin the housing, with the reaction occurring on a reactive membraneon the side of the device opposite the sample well, with the devicehaving a window for viewing the results.

Referring now to FIG. 18, there is illustrated a cross-sectional view ofone embodiment of the vertical immunoassay device 1700. There is shownone of the plurality of immunoassay test pads 1704 residing within thehousing 1702 below one of the plurality of sample wells 1706. The one ofthe plurality of immunoassay test pads 1704 includes an immunoreactivemembrane 1802, such as the nitrocellulose membranes disclosed herein.The immunoreactive membrane 1802 may have particle conjugates disposedthereon that binds when a biologic sample is received onto theimmunoreactive membrane 1802 via the sample well 1706, if the biologicsample contains the antigens or antibodies, or other indicators, forwhich the test is configured. The one of the plurality of immunoassaytest pads 1704 also includes an absorbent pad 1804 for collection ofexcess biologic sample. It will be understood that the cross-sectionalview illustrated in FIG. 18 shows one well of the plurality of samplewells 1704. The other wells included in the device 1700 would beconfigured in a similar manner as that shown in FIG. 18. There may alsobe included in the device 1700 an inner separating wall between each ofthe plurality of immunoassay test pads 1704, to ensure that excessbiologic material that is not adequately absorbed by the absorbent pad1804 does not contaminate neighboring immunoassay test pads.

Referring now to FIG. 19, there is illustrated a color gradient chart1900. When the mobile application described herein captures an image ofthe testing device, in some embodiments each pixel that makes up thetest line captured in the image is processed to place it on a colorgradient scale. In some embodiments, this placement may be done byexamining the RGB color values of the pixel. For any given test, theremay be a visual color indicator (such as a test line) presented to theuser of the test to indicate whether a reaction occurred. The color thatis to be presented is known for the given test. Additionally, in someembodiments, the strength of the reaction will affect the strength ofthe color indicator. For example, if a test is supposed to produce abrown colored indicator, an image can be taken of the colored indicatorto examine each pixel of the colored indicator to determine the strengthof the color produced on the testing device, which indicates thestrength of the reaction, and thus the risk level for the user.

The embodiment illustrated in FIG. 19 uses as an example a set of pixelRGB results for a test that produces a red colored indicator on the teststrip when a reaction has occurred. There can be seen an origin point1902 on the chart 1900, wherein the RGB color value is (255, 255, 255)or white. This may represent a no reaction state for the test strip,since the test line on the strip may only appear as a white blank spaceif no reaction has occurred. An x axis 1904 represents the color green,wherein the amount of green in the pixel decreases as it moves away fromthe origin in relation to the x axis 1904. A y axis 1906 represents thecolor blue, wherein the amount of blue in the pixel decreases as itmoves away from the origin in relation to the y axis 1906. A diagonalline 1908 running in between the x axis 1904 and the y axis 1906represents the color red, wherein the diagonal line 1908 running throughthe center of the chart 1900 is a maximum red color all along thediagonal line 1908. If a pixel has less red than a 255 value, the pixelwould be plotted away from the diagonal line 1908 in relation towhichever color is more predominant. For instance, if the pixel has RGBcolor values of (127, 50, 205), a shade of purple, the pixel would beplotted somewhere in the lower right quadrant of the chart 1900. FIG. 19further illustrates an example plurality of pixel plot points 1910,connected by a curved line, wherein the example plurality of pixel plotpoints 1910 shows tests results that likely indicate a positivereaction, as the plot points are all located near the diagonal line1908, demonstrating that the colored indicator was a heavy red color forthe most part.

Referring now to FIG. 20, there is illustrated a normalized past testsresults chart 2000. The captured pixels may be normalized into a singlevalue for determining whether there is a likelihood of infection,pregnancy, or whatever else the test is designed to detect. This may bedone in various ways. For example, the shade of red in all the pixelsmay be averaged to reach a single RGB value. Outliers may be left out sothat the average is not heavily skewed, especially when there are fewoutliers present. This RGB value may then be given a value, such as arisk rating, ranging from 0 to 100. For example, an RGB value of (255,255, 255) would be given a rating of 0. An RGB value of (255, 0, 0)would be given a rating of 100. An RGB value of (205, 150, 75) may begiven a rating of 70, and so on. This normalized value may then be usedto compare the user of the test to users of past tests to determine arisk level. In some embodiments, the control line and the test line maybe captured and the results compared, as well. In addition, the realresults of risk levels may also be used to adjust the stored normalizedvalue. For instance, if a particular RGB value that seems to indicate astrong reaction repeatedly was found to not indicate an infection, thisvalue may be adjusted to provide a lower risk rating. For instance, if aphysician who saw a patient who had a (205, 150, 75) RGB value laterreported to the operator of the server 1206 that further testing showedno infection was present, and if this trend continued substantially asreported by other physicians or medical organizations, subsequent testresults by other test users that were near the RGB value of (205, 150,75) may be given a lower rating.

Chart 2000 illustrates how past tests results may be collected and usedto determine the risk of a current test user. A y axis 2002 represents arisk level rating, ranging from 0 at the origin to 100. An x axis 2004represents time, wherein a plurality of normalized test results isplotted on the chart 2000. The chart 2000 is further divided intosections across the y axis 2002, indicating various risk levelthresholds. For instance, and as illustrated in the chart 2000, theremay be at certain rating levels different thresholds of risk labeled aslow, moderate, above average, and high risk levels. These thresholds maybe moved over time as more data is accumulated via users conductingtests and the mobile application storing the data on the tests. When auser conducts a test, the user's normalized rating can be plottedsimilarly to past test results and weighed against them in order toprovide a risk level for the user.

Referring now to FIG. 21, there is illustrated the mobile device 802displaying on the screen 804 a mobile application variable testfunctionality. There is displayed on the screen 804 a plurality of testfunctions 2102. The plurality of test functions 2102 may be buttons thatcan be selected by a user to switch between tests within the mobileapplication. This allows for all test functions to be within the samemobile application. For each test run by the mobile application, datafor the particular test chosen is utilized in performing the test,pulling the data from the remote server 1206.

Referring now to FIG. 22, there is illustrated the mobile device 802 ofFIG. 8B, wherein the housing 302 of the testing device 300 also includesthereon test function indicators 2202 and 2204. The test functionindicators 2202 and 2204 are visual markers located on the housing 302that identify to the mobile application the types of tests for which thetesting device 300 is configured. These indicators may be any symbol,alphanumeric character, shape, etc. that can be added to the surface ofthe testing device 300. The mobile application is programmed torecognize the indicator and perform the test function associated withthe indicator. For example, the embodiment illustrated in FIG. 22 showsa “P” symbol for test function indicator 2202 and a “Z” symbol for testfunction indicator 2204. In this embodiment, test function indicator2202 indicates that one test strip in the testing device 300 is apregnancy test, while test function indicator 2204 indicates that onetest strip in the testing device 300 is a Zika test. This is used formerely illustrative purposes, and any recognizable symbol may be usedfor these two test functions, and any other type of test may have asymbol assigned in this way as well. Further, in some embodiments theremay only be one indicator on the housing 302, even if there are multipletests. This single indicator would be for the combined test. Forexample, if the testing device 300 of FIG. 22 had a single symbol of“PZ,” this would indicate that the testing device 300 is a combinedpregnancy and Zika testing device, allowing for the mobile applicationto recognize such and perform each test with knowledge of which strip isassociated with which test based on the stored data on the testingdevice associated with the “PZ” symbol.

Referring now to FIG. 23, there is illustrated a medical codecorrelation system 2300. The system 2300 includes a mobile device 2302,which is configured to run the mobile application described herein. Themobile device 2302 is connected to a database 2304 disposed on a server2306, over a network 2308. To correlate a medical code, the mobiledevice first passes a diagnostic test identifier to the remote server.This identifier allows for the type of test being used by the user ofthe mobile device 2302 to be determined. The identifier may simply bethe name of the test, may be a number associated with the test, or anyother means of identifying the test being performed by the user of themobile device 2302. This may be done when the phone capture the image ofthe testing device to process the results, or the user may enter thetest to be performed before a test is conducted, at which time themobile device 2302 may pass the identifier to the remote server. Inother embodiments, the diagnostic test identifier may even be themedical code. For example, if the diagnostic test is a strep test, theidentifier may be G0435, an HCPCS code for a rapid immunoassay test, orany other appropriate medical code.

Once the physical test results of the diagnostic test is captured, andonce the results are processed by the mobile device 2302 or the server2306, the results are also received by the server. Once the server 2306has the diagnostic test identification and the results of the test, theserver 2306 may then correlate the specific test and the results withappropriate medical codes stored within the database 2304. It will beunderstood that the database 2304 may be physically located with theserver 2306, or the database 2306 may be a remote database, such as acentralized database that allows entities within the healthcare industryto retrieve the latest medical codes. The medical codes assigned maythen be transferred from the mobile device 2302 to a healthcare entity2310. In other embodiments, the medical codes may be transferred fromthe server 2306 to the healthcare entity 2310. The healthcare entity2310 may be a physician, a hospital, a pharmacy, an insurance company,or any other entity that may provide the user with further assistance.

Referring now to FIG. 24, there is illustrated a strep home retail testcodes table 2400. The table 2400 lists the various medical codes thatmay be associated with a home testing device that is used to test for astreptococcal infection. The table 2400 is representative of the typesof codes that may be stored in the database 2304 in relation to aparticular retail strep test device. The table 2400 lists a diagnosiscode of J02.0, an ICD-10-CM code for streptococcal pharyngitis. Thetable 2400 also lists an HCPCS code of G0435, which is a code for arapid antibody test. The table 2400 also lists an NDC code of54569-5182-0, which is the NDC code for an amoxicillin prescription.Thus, when the server 2306 assigns the medical codes to the testingdevice or the test results, various codes may be produced. The exampleshown in table 2400 shows that the strep home retail testing device isassigned the HCPCS code of G0435 to indicate the type of test it is, arapid antibody test. If the test results come back as positive, theserver assigns the ICD-10-CM code to this event, indicating astreptococcal throat infection. In response to these positive testresults, the server 2306 provides the NDC code for amoxicillin as arecommended prescription to give to the user to treat the infection.

In some embodiments, this prescription may be passed to a pharmacy sothat the pharmacy may fill the prescription for the user to pick up, orto be delivered to the user. In some embodiments, the medical codes andother information may be passed to a physician for review. Thisphysician may be the primary care physician of the user, allowing theuser to set an appointment to go over the test results and get aprescription from the physician. In other embodiments, the physician maybe a telemedicine physician that either the user contacts, the physiciansets up a telemedicine conference, or the system described hereinautomatically initiates in response to the test results. The physicianmay alter the recommended prescription provided by the system, mayconduct additional testing, or otherwise handle the situation as he orshe sees fit as a physician. In addition, in some embodiments, themedical codes may be passed to an insurance company to seekreimbursement for the testing device, the prescription, the visit withthe physician, or any other costs that arise from this testing event. Toaccomplish such, the user may have provided his or her insuranceinformation when signing up to use the mobile application in conjunctionwith the various testing devices provided.

Referring now to FIG. 25, there is illustrated a combined pregnancy andZika home retail test codes table 2500. The table 2500 lists the variousmedical codes that may be associated with a home testing device that isused to test for both pregnancy and a Zika infection. The table 2500 isrepresentative of the types of codes that may be stored in the database2304 in relation to a particular retail pregnancy/Zika testing device.The table 2500 has a pregnancy codes column and a Zika codes column. Thepregnancy codes column lists a diagnosis code of Z33.1, an ICD-10-CMcode for a pregnant state. The pregnancy codes column also lists anHCPCS code of G8802, which is a code for a pregnancy test. The pregnancycodes column also lists an NDC code of 42192-321-30, which is the NDCcode for prenatal vitamins. The Zika codes column lists a diagnosis codeof A92.5, an ICD-10-CM code for the Zika virus. The Zika codes columnalso lists an HCPCS code of G0435, which is a code for a rapid antibodytest. The Zika codes column also lists an NDC code of 50580-501-30,which is the NDC code for prescription strength Tylenol. In someembodiments, instead of separate codes for each type of test performed,there may be a single code assigned to, for example, a combinedpregnancy and Zika test, or even a single code for a pregnant with Zikainfection state.

It will be understood that the codes listed in FIGS. 24-25 are examplesof how the system may assign codes to a testing event. The use of thespecific codes and the types of codes (ICD-10-CM, HCPCS, and NDC codes)are merely used for illustrative purposes; any type of codes may be usedand the specific codes listed in FIGS. 24-25 may be other, moreappropriate, codes for the particular testing device, diagnosis, etc.Different types of codes include, but are not limited to, ICD-9-CM,ICPC-2, NANDA, Read code, SNOMED, CCI, CDT, NIC, NMDS, NOC, CCAM,OPCS-4, or other codes.

Referring now to FIG. 26, there is illustrated a flowchart of oneembodiment of a medical code correlation process 2600. The processbegins at step 2602 where the mobile device 2302 running the applicationdescribed herein transmits a diagnostic test identifier to the remoteserver 2306. At step 2604, the remote server 2306 correlates thediagnostic test identifier with a medical code associated with theparticular diagnostic test. This identifier allows for the type of testbeing used by the user of the mobile device 2302 to be determined. Theidentifier may simply be the name of the test, may be a numberassociated with the test, or any other means of identifying the testbeing performed by the user of the mobile device 2302. This may be donewhen the phone capture the image of the testing device to process theresults, or the user may enter the test to be performed before a test isconducted, at which time the mobile device 2302 may pass the identifierto the remote server. In other embodiments, the diagnostic testidentifier may even be the medical code. For example, if the diagnostictest is a strep test, the identifier may be G0435, an HCPCS code for arapid immunoassay test, or any other appropriate medical code.

The process then flows to step 2606, where the mobile device 2302, aspart of the overall operation of the system and mobile applicationdescribed herein, capture an image of the testing device for processing.At step 2608, the image is processed to achieve the test results. Suchprocessing may be performed on the mobile device 2302, on the remoteserver 2306, another server, or any other device that may be interfacedwith the system disclosed herein. The process then flows to decisionblock 2610, where it is determined whether the test results indicated apositive result (positive infection, pregnancy, or other outcomes). Ifthe test result is positive, the process flows to step 2612, where theremote server 2306 correlates a medical code with the test results. Asdescribed herein, components other than the remote server 2306 maycorrelate the test results with a medical code, such as a centralizedserver and database used in the healthcare industry to retrieve medicalcodes. The process then flows to step 2614 to assign a recommendedpharmaceutical product based on the test results. This may be an NDCcode for a product, and there may even be provided a prescription forsuch. At step 2616, the codes are transmitted to the appropriatehealthcare entities, such as a physician, a pharmacy, or other entities.

If at decision block 2610 it is determined that the test results arenegative, the process instead flows to step 2618, where no medical codeis correlated with the test results. This provides that no diagnosiscode if provided, since the test results indicate that the user is notpositive for the condition being tested. However, a medical code for thetest itself, determined at step 2604, may still be applicable in thisscenario, because the user still used the diagnostic test, and thereforemay still be reimbursed for the cost of the test, if the user'sinsurance company chooses to do so. The user's physician may also wantto see the test results, even if they are negative, and the code for thetest and the negative results may still be transmitted to the physician.Therefore, after step 2618, the process then flows to step 2616 totransmit the codes (in this case, the code for the testing deviceproduct) to the appropriate healthcare entities. The test resultsthemselves may also be transmitted.

Referring now to FIG. 27, there is illustrated one embodiment of atelemedicine initiation option within a mobile application. The mobileapplication and system described herein is predominantly meant to firsttest a patient for a medical condition, and then recommend an action,such as seeing a physician. However, the system allows for telemedicineconferences to be initiated, and therefore functionality may existwherein a user can request a telemedicine conference with a physician atany time while using the mobile application, in order to receive adiagnosis or simply to ask questions. Thus, FIG. 27 again shows theplurality of test functions 2102 displayed on the screen 804. Inaddition to these options, an additional option is presented to theuser. This option is a telemedicine conference button 2702 that allows auser to initiate a telemedicine conference with a qualified telemedicineprovider. This button 2702 is shown on the screen where the user selectsthe type of test to be performed, but the button 2702 may be presentedwithin the user interface on any screen of the mobile application.

Referring now to FIG. 28, there is illustrated another embodiment of atelemedicine initiation option within a mobile application. There isshown on the screen 804 the test results as previously shown on FIG. 22,which indicate positive pregnancy and Zika test results. In such asituation where the test results indicate a possible serious medicalcondition, a button 2802 may appear to the user on the screen 804. Thebutton 2802 may have a warning message within, urging the user to seek aconsultation with a physician to talk about the user's options in lightof the positive test results, and inviting the user to tap the button2802 to initiate a telemedicine conference with a physician. Tapping thebutton 2802 will initiate such a telemedicine conference. The physicianthat is connected with for the conference may be an on-call physicianthat has agreed to make his or her services available through the systemdescribed herein, the telemedicine conference may use an existedtelemedicine conference platform and physician base, the user's primarycare physician may be a user of the system and mobile application,allowing for them to be used as the default telemedicine contact for theuser, or other methods of making physicians available for a conferencewith the users of the mobile application may be provided.

Referring now to FIG. 29, there is illustrated one embodiment of atelemedicine conference session on a mobile device. During atelemedicine conference that has been initiated as described herein, theuser is presented with a video conference window 2902 on the screen 804.The video conference window 2902 allows for user to see the physicianthat is providing the telemedicine services to the user. It will beunderstood that the physician may have a similar video window on thedevice being used by the physician that allows the physician to see theuser. This allows the physician to make some visual observations of theuser's condition. In addition to the video conference window 2902, theuser is presented with a plurality of actions 2904 on the screen 804.The plurality of action 2904 may be buttons that allow the user toprovide the physician with further information. For example, one buttonmay allow for the user to send a photograph to the physician, such as aphotograph of the user's symptoms, or of the user's test resultspresented on the testing device. One button may also provide an optionfor sending the user's medical file to the physician, so that thephysician can review the user's medical history or other importantinformation. This medical file may include all the informationaccumulated from all tests performed by the user under the systemdescribed herein, and may also include all other medical historyinformation. The user may have provided a copy of his or her medicalhistory, or such may have been retrieved from a central electronicmedical records system.

Other actions that may be provided in the plurality of actions 2904 maybe a button to send test results to the physician. This would allow theuser to send the test results of the latest test the user took beforeinitiating the telemedicine conference, or it may allow for the user tochoose the test. The plurality of actions 2904 may also include a buttonfor sending the user's insurance information to the physician. The usermay have provided this information within the mobile application and hadit stored to the server, or this information may have been pulled forthe user based on the user's identification information. This optionallows the user to give the physician insurance information so that thephysician can use the user's insurance for reimbursement of thetelemedicine services, and may even set up reimbursement to the user forcertain services or products, such as the testing device used for thetest.

Referring now to FIG. 30, there is illustrated a flowchart of oneembodiment of a medical file handoff process 3000. The process 3000starts at step 3002 where a user is provided with diagnostic testresults at the conclusion of a performance of a test. At decision block3004, it is determined whether the test results provide a positiveresult. If not, at step 3006 the results are stored on the server of thesystem described herein and the process ends at end block 3016. If theresults are positive, the process flows to step 3008 where the resultsare stored on the server. At step 3010, it is determined whether atelemedicine conference has been initiated. This initiation may havebeen selected as described with respect to FIGS. 27 and 28, may havebeen initiated automatically due to the results provided, or may havebeen initiated in some other way. If the telemedicine conference was notinitiated, the process ends at end block 3016. If the telemedicineconference was initiated, the process flows to step 3012 where the testresults are passed to the telemedicine provider participating in thetelemedicine conference. The process then flows to step 3014, whereother user information is passed to the telemedicine provider. Theprocess then ends at end block 3016.

The passing of the results to the telemedicine provider and otherinformation at steps 3012 and 3014 may be performed by the user's mobiledevice, wherein the mobile device sends the files to the telemedicineprovider. The passing may also be done by the server of the systemdescribed herein, wherein the results and other information waspreviously stored to the server and the server then passes the resultsand other information to the telemedicine provider as a result of theserver being notified of a telemedicine conference initiation. The otheruser information of step 3014 may be any information needed by thetelemedicine provider, such as past medical records and history of theuser, past test results, insurance information, or any otherinformation.

Referring now to FIG. 31, there is illustrated a flowchart of oneembodiment of a telemedicine conference initiation process 3100. Theprocess 3100 starts at step 3102 where a user is provided withdiagnostic test results at the conclusion of a performance of a test. Atdecision block 3104, it is determined whether the test results provide apositive result. If not, at step 3106 the results are stored on theserver of the system described herein and the process ends at end block3118. If the results are positive, the process flows to step 3108 wherethe results are stored on the server. At step 3110 a telemedicine buttonis presented to the user on the screen of the mobile device, similar tothat shown in FIG. 28. This button recommends to the user that the userinitiate a telemedicine conference, since the test results indicate apositive reaction. At step 3112, it is determined whether a telemedicineconference has been initiated. This initiation may have been selected asdescribed with respect to FIGS. 27 and 28, may have been initiatedautomatically due to the results provided, or may have been initiated insome other way. If the telemedicine conference was not initiated, theprocess ends at end block 3118. If the telemedicine conference wasinitiated, the process flows to step 3114 where the test results arepassed to the telemedicine provider participating in the telemedicineconference. The process then flows to step 3116, where other userinformation is passed to the telemedicine provider. The process thenends at end block 3118.

The passing of the results to the telemedicine provider and otherinformation at steps 3114 and 3116 may be performed by the user's mobiledevice, wherein the mobile device sends the files to the telemedicineprovider. The passing may also be done by the server of the systemdescribed herein, wherein the results and other information waspreviously stored to the server and the server then passes the resultsand other information to the telemedicine provider as a result of theserver being notified of a telemedicine conference initiation. The otheruser information of step 3116 may be any information needed by thetelemedicine provider, such as past medical records and history of theuser, past test results, insurance information, or any otherinformation.

Resolution of test results as described above requires accurate colordetermination. However, cameras incorporated into mobile devices such assmart phones differ from phone to phone and model to model. The opticaldesign of the cameras used in smart phones varies with differentmanufactures and models with varying degrees of chromatic aberration andlens-light interactions that can affect the color balance of capturedimages. Different hardware sensors are used in different mobile devicesto detect lighting conditions and adjust image acquisition parameters.Further, image and color correction algorithms incorporated intodifferent models of smart phones will not necessarily produce the samecolors and intensity of images. Image correction algorithms incorporatedinto many mobile devices are designed to produce images that arepleasing to the eye of the viewer, e.g., provide acceptable contrast,color intensity and brightness. These algorithms may adjust the colorand intensity of colors in captured images. Additionally, variations inmanufacturing and components such as lenses can add to differences inthe coloration of captured images.

Environmental factors may also introduce variations. Lighting, the angleof the camera, and other factors such as dust or other material on thecamera lens may affect image capture and color reproduction. Thus,different images acquired with the same and different mobile devicessuch as smart phones will have differing and unique color balances. Aparticular color, for example a “red” in one image, will not necessarilymatch the “red” in another image, regardless of the color space used torepresent the image, e.g. sRBG, HSV. etc. Consequently, there is a needto insure that test images captured by mobile devices as describedherein provide consistent accurate color results.

Referring to FIG. 32, in one embodiment, a test strip 3200 issubstantially similar to test strip 100 of FIG. 1. Test strip 3200 ismade up of multiple sections disposed on the backing 3202. A sample pad3204 is disposed near a first end of strip 3200 with a particleconjugate pad 3208 disposed between sample pad 3204 and a test line3210. A control line 3212 provides a comparative example for a userreading the test. A wick 3216 is provided to absorb analyte applied tothe strip as described in connection with FIG. 1. As illustrated, teststrip 3200 includes a color mosaic 3220 at an end of the strip. Colormosaic 3220 includes a plurality of different color tiles 3222.Depending upon the particular test, e.g., the anticipated color orcolors of test line 3210 and control line 3212 upon completion of thetest, the number of tiles of a particular color or color range may bebiased to include more tiles of the anticipated color range and/orshades of the anticipated color or colors upon completion of the test.In other words, if the anticipated color of test line 3210 and controlline 3212 is red, a relatively large number of color tiles 3222 may becolored red or different shades of red. Color mosaic 3220 may be appliedto strip 3220 by imprinting the color mosaic on the strip or applied asan adhesive label or sticker.

FIG. 33 is a diagrammatic illustration of one color mosaic 3300. Colormosaic 3300 includes a plurality (6 illustrated) of color blocks 3302.In different variations a single color block or other geometries may beused. Each colored block 3302 is subdivided into color tiles 3304 ofdifferent colors and shades of colors that may be used for colorcorrection of test results as hereinafter described. The use of multiplecolor blocks 3302 provides a means of cross-checking since thearrangement and color of each of tiles 3304 is the same in each of theblocks. Depending upon the anticipated results of a test, the colors oftiles 3304 may be biased to include a larger number of tiles of theanticipated color of the test result and shades of that color. Forexample, if the anticipated color of the test strips upon completion ofthe test is red, then color matrix 3212 may biased to include more “red”tiles than “green” or “blue” tiles. Although as illustrated, colormosaic is comprised of a plurality of rectangular blocks, in differentvariations color mosaic could be circular, ring-shaped or a differentgeometry with different colors displayed in different areas of themosaic.

Referring now to FIG. 34, a top view of one embodiment of a testingdevice 3400. Device 3400 is configured to receive a plurality of teststrips 3404, the same as or similar to strip 3200 of FIG. 32. Device3400 includes a housing 3402 that may be made of plastic, metal, orother suitable material. Housing 3402 is configured such that one ormore test strips 3404 may be contained therein with portions of thestrips visible through windows 3406. Windows 3406 may be open or coveredwith a suitable transparent material to allow observation of at leasttest and control lines 3410, 3412 and a color mosaic 3414. Asillustrated, color mosaic 3414 includes a plurality of different coloredtiles 3416 which may be biased toward the anticipated color or colors ofthe test and control lines after contact with the analyte.

Housing 3402 includes one or more sample wells 3408 disposed on asurface of the housing to receive a biologic into the housing and ontothe test strip as described herein. In one embodiment, a single samplewell 3408 is included for collection of a single type of biologic fortesting, with each of strips 3404 selected to test for antigens usingthat particular biologic sample type, (i.e. blood, urine, saliva et.).In other embodiments multiple sample wells, each associated with one ormore strips, may be provided to enable testing using differentbiologics.

Device 3400 may include an alignment target 3410 (crosshair illustrated)printed or adhered to the device. Alignment target 3410 is provided toalign device 3400 with a camera of a mobile device such as a smart phoneto capture an image of the device including at least test and controllines 3410, 3412 and color block 3414. Alignment target 3410 may one ofany number of different symbols or insignia and may be imprinted ondevice 3400, applied as an adhesive label or otherwise applied to thedevice.

FIG. 35 is a top view of an embodiment of a testing device 3500. Device3500 is substantially similar to device 3400 of FIG. 34 with a housing3502, one or more sample wells 3508, an alignment target 3510 andwindows 3506 to enable viewing of test strips 3504. The embodimentillustrated in FIG. 35 further includes a color mosaic 3514 applied tohousing 3502. Color mosaic 3514 includes a plurality of tiles 3516 ofdifferent selected colors. Color mosaic 3514 may be imprinted on housing3502, applied as an adhesive label or otherwise placed on the housing.In the case where device 3500 is used with multiple different teststrips to perform multiple tests, different mosaics may be supplied withdifferent test strips as adhesive labels and selectively applied tohousing 3502 depending upon the particular test or tests to be performedwith the device. Depending upon the anticipated results, (color orcolors of the test and control lines), the colors of tiles 3504 may bebiased to include a larger number of tiles of the anticipated color orcolors of the test and control lines.

A medical test code 3520 or codes may also be imprinted on or applied todevice 3500. Test code 3520 may be a representation of an ICD-10-CM codeor similar code associated with the underlying condition that is thesubject of the test. A device identification code 3522 may also beimprinted on device 3500. Device identification code 3522 may be uniqueto the specific device or to a group of devices. In the case wheredevice 3500 is provided to a user with one or more selected test strips,device code 3500 may be used to insure that the device is used with theintended test or tests. In some embodiments, similar medical test codesor identification codes may be imprinted or applied to test strips, suchas strip 3200 of FIG. 32.

FIG. 36 is a top view of a mobile device 3600 using an application fortesting device image capture and image processing. The mobile deviceapplication allows for an image of a testing device, such as testingdevice 3500, to be captured using a camera installed on mobile device3600 having a screen 3604. While the mobile device 3600 displays on thescreen 3604 the scene captured by the camera, the mobile deviceapplication may also display a graphic on the screen 3604 in the form ofa boxed outline 3608, similar or identical to outline 806 of FIG. 8A,the outline corresponding to the size of the testing device 3600. Alsodisplayed on the screen of the mobile device 3600 is an alignmentgraphic 3608. A user of the mobile device 3600 aligns the outline withthe borders of the testing device 3500 and also aligns the alignmentgraphic 3608 with the alignment target 3510 on the testing device 3500until the outline and the alignment graphic 3608 are superimposed uponthe test device 3500 and alignment target 3510 as illustrated. Asdescribed in connection with FIG. 8B, a success indicator may appear,such as a check mark or other positive status symbol, on the alignedimage when the alignment is successful. In one embodiment, successfulalignment causes the camera on the mobile device 3600 to capture thecurrent image of the testing device 3500. Other checks may occurincluding ensuring that the image is focused before the image is saved.

The captured image of testing device 3500 also includes color mosaic3515. The mobile device application recognizes color mosaic 3514 basedupon its position in the captured image and/or other criteria, such asthe arrangement of color tiles 3516 or a code imprinted with the colormosaic. The inclusion of the color mosaic in the captured image providesa means of calibrating and interpreting the results of the test.

FIG. 37 is a flowchart 3700 of one embodiment of an image analysisprocess using mobile device 3600 and device 3500. The process begins at3702 with initialization of the application on the mobile device 3600(FIG. 36). The user may be required to identify the particular test ordevice by entering an associated code or selecting a test from adisplayed menu of tests. The user collects the biologic, e.g. blood,urine, saliva, at 3704 and places the sample in the sample well 3508(FIG. 36). The user aligns the testing device 3500 with the mobiledevice camera at 3706 and an image of the testing device is captured at3708. Correct alignment of the mobile device camera with the testingdevice may be used by the application to trigger the mobile device toactivate the camera to capture an image of the test device. In otherembodiments, the application may require proper alignment or alignmentwithin a certain range, for example plus or minus 1 mm or 0.5 mm, beforea user may activate the camera to capture an image of the test device.

Processing of the captured image with the mobile device is initiated at3710. Initial steps in the image process may include determining if theimage is resolvable at 3712. If, for some reason, such as a dirty cameralens or insufficient lighting, the image cannot be resolved, an errormessage is displayed on the mobile device screen at 3714 and the processended before the image is saved. The application may also check todetermine if the test device is recognized, for example, if the image ofthe test device does not fit the expected profile or if a deviceidentification code 3522 (FIG. 35) is not recognized, an error messagemay be displayed at 3714 and the process terminated.

At 3718, the color mosaic 3514 (FIG. 35) in the captured image isidentified and the color values for all or selected ones of color tiles3516 determined. For example, each pixel corresponding to a color tilein the color matrix of the captured image is assigned a RGB value. Afterthe color values for the captured image color matrix are determined,known values for the colors in the matrix may be retrieved at 3720. Theknown values may be stored on a database associated with remote server,such as server 1206 of FIG. 12, and/or transmitted to mobile device 3600for comparison with the color values of the color matrix in the capturedimage at 3722. For example, a RBG value may be established for eachcolor tile 3516 in the captured image and compared to the known RBG ofthe color tile. This step may be performed with mobile device 3600 orwith the remote server. The comparison may also be done by downloadingthe known values to mobile device 3600 which then conducts thecomparison or, if the values for the color matrix in the captured imagehave be transmitted to a remote server 1206, the comparison of the colorvalues from captured image with the known values may be done with theserver. The comparison may be done on a pixel-by-pixel basis for eachcolor tile 3516, or the color values for the pixels within each colortile in the image may be averaged and compared to a known color valuefor the particular color tile.

After comparison, the differences between the color values of thecaptured image of the color mosaic and the known color values may bechecked to determine if the differences are within a predeterminedacceptable range at 3724. For example, if the red, green and blue values(RGB) for the different color tiles 3516 of the color mosaic in thecaptured image were all within a range of −5 to +5 of the known values,the color values of the captured image may be determined to beacceptable in which case, no color correction is necessary and theprocess skips to 3728.

If the color values of the color matrix of the captured image are notwithin an acceptable range when compared to the known values, a colorshift factor or correction may be determined at 3726. The color shiftfactor may be determined with an algorithm that uses the differencesbetween the color values of the color mosaic of the captured image andthe known color values to determine a color shift factor or factors.

The test line is identified at 3728 and the colors of the test linepixels determined. In one variation, the color of the test line may bedetermined as an average color value of the pixels of the test line. Ifa color correction or shift has been determined at step 3726, the colorshift factor or factors may then be applied to the pixels of the testline (or to the average color value) at 3730 to obtain corrected values.After the corrected values for the pixels of the test line are obtained,the results are processed at 3732, positive and negative resultsdisplayed on screen 3604 (FIG. 36) and the results processed asdescribed herein. The process ends at 3734.

FIG. 38 is a top view of another embodiment of a testing device 3800.Device 3900 is substantially similar to device 3400 of FIG. 34 with ahousing 3802, one or more sample wells 3808, an alignment target 3814and windows 3806 to enable viewing of test strips 3804 including testlines 3810 and control lines 3812. A color mosaic 3816 is positioned ontesting device 3800 adjacent each of test lines 3810 and control lines3812. Color mosaic 3816 may include color tiles 3820 of different shadesof a single color. For example, if the expected result of a positivetest is red, color mosaic 3816 will include color tiles 3820 ofdifferent shades of red corresponding to a positive test result. In onevariation, color mosaic 3816 may include a single color shadecorresponding to a positive test result.

Color mosaic 3816 may be imprinted on housing 3802, applied as anadhesive label or otherwise placed on the housing. In the case wheredevice 3800 is used with multiple different test strips to performmultiple tests, different mosaics 3816 are applied to housing 3802 orsupplied with different test strips as adhesive labels and selectivelyapplied to housing 3802 depending upon the particular test or tests tobe performed with the device. In another variation, color mosaic 3816may be applied to test strips 3804 similar to color mosaic 3220 of FIG.32. In this case, the color mosaic could be exposed through a window ina test device similar to window 3406 of FIG. 34.

FIG. 39 is a top view of a mobile device 3900 using an application fortesting device image capture and image processing. The mobile deviceapplication allows for an image of a testing device, such as testingdevice 3800, to be captured using a camera installed on mobile device3900 having a screen 3904. While the mobile device 3600 displays on thescreen 3604 the scene captured by the camera, the mobile deviceapplication may also display a graphic on the screen 3604 in the form ofa boxed outline 3906, similar or identical to outline 806 of FIG. 8A,the outline corresponding to the size of the testing device 3600. Analignment graphic 3908 may be displayed on screen 3904 of the mobiledevice 3900.

A user of the mobile device 3900 aligns outline 3906 with the borders oftesting device 3800 and may also align graphic 3908 with the alignmenttarget 3814 on the testing device 3800 until the outline and thealignment graphic 3608 are superimposed upon the test device 3500 andalignment target 3814 as illustrated. As described in connection withFIG. 8B, a success indicator may appear, such as a check mark or otherpositive status symbol, on the aligned image when the alignment issuccessful. Successful alignment may be a trigger that causes the cameraon the mobile device 3900 to capture the image of the testing device3800. Other checks may occur including ensuring that the image isfocused before the image is saved.

The captured image of testing device 3800 also includes color mosaic3816. The mobile device application recognizes color mosaic 3816 basedupon its position in the captured image and/or other criteria, such acode imprinted with the color mosaic. Color mosaic 3816 in the capturedimage provides a means of interpreting the results of the test.

FIG. 40 is a flowchart 4000 of one embodiment of an image analysisprocess using mobile device 3900 and device 3800. The process begins at4002 with initialization of the application on the mobile device 3900.The user may be required to identify the particular test or device byentering an associated code or selecting a test from a displayed menu oftests. The user collects the biologic, e.g. blood, urine, saliva, at4004 and places the sample in the sample well 3808. (FIG. 38). The useraligns the mobile device camera with testing device 3900 with the mobiledevice camera at 4006. When the testing device 3800 is aligned with themobile device camera an image of the testing device is captured at 4008.Correct alignment of the mobile device camera with the testing devicemay be used by the application to trigger the mobile device to activatethe camera to capture an image of the test device. In other embodiments,the application may require proper alignment or alignment within acertain range, for example plus or minus 1 mm or 0.5 mm, before a usermay activate the camera to capture an image of the test device.

Processing of the captured image with the mobile device is initiated at4012. Image processing may include determining if the image isresolvable at 4012. If, for some reason, such as a dirty camera lens orinsufficient lighting, the image cannot be resolved, an error message isdisplayed on the mobile device screen at 4014 and the process endedbefore the image is saved. The application may also check to determineif the test device is recognized, for example, if the image of the testdevice does not fit the expected profile or if a device identificationcode such as code 3522 (FIG. 35) is not recognized, an error message maybe displayed at 4014 and the process terminated.

At step 4018, color mosaic(s) 3816 are identified in the captured image.The test line or lines 3810 and control lines 3812 are identified in thecaptured image at 4020 and the color values of the images of the pixelsof the test and control lines are determined. The color values of thepixels of the test and control line images may be averaged to obtain asingle value for comparison. The color values of the pixels of the imageof the test line (or the average color value) are compared to the colorvalues of the image of color mosaic at 4022. If the color values of thepixels of the test line (or the average value) fall within apredetermined range of the color or colors of the color mosaicindicating a positive test result, for example ±5% or within apredetermined range of RGB color values, a positive test result isdetermined at 4026. If the color values of the pixels of the test line(or the average) fall outside of the predetermined range, a negativetest result is determined at 4028. The positive or negative test resultsmay be displayed on screen 3904, similar to FIG. 8B and FIG. 22, and theresults processed as described herein. The process ends at 4030.

It should be understood that the drawings and detailed descriptionherein are to be regarded in an illustrative rather than a restrictivemanner, and are not intended to be limiting to the particular forms andexamples disclosed. On the contrary, included are any furthermodifications, changes, rearrangements, substitutions, alternatives,design choices, and embodiments apparent to those of ordinary skill inthe art, without departing from the spirit and scope hereof, as definedby the following claims. Thus, it is intended that the following claimsbe interpreted to embrace all such further modifications, changes,rearrangements, substitutions, alternatives, design choices, andembodiments.

1. A system for providing immunoassay test results for medicalconditions, comprising: a testing device configured to collect at leastone biologic, the testing device including at least one immunoassay teststrip, the at least one immunoassay test strip including: a conjugatepad including particles configured to conjugate with the at least onebiologic to create an immune complex, and a membrane strip including atest line, the test line configured to receive the immune complex,wherein the test line includes particular antigens or antibodies,wherein, if the immune complex contains antigens or antibodies capableof binding with the particular antigens or antibodies included on thetest line, the antigens or antibodies of the immune complex bind to theantigens or antibodies of the test line, and wherein the test line isconfigured to produce a qualitative response if the antigens orantibodies of the immune complex are bound to the antigens or antibodieson the test line; a software application stored on a mobile device, themobile device including a camera and a viewing screen, wherein thesoftware application, when executed, causes the mobile device to:present an outlined area on the viewing screen to be aligned withborders of the testing device; present on the viewing screen analignment graphic to be aligned with an alignment target of the testingdevice, wherein the alignment graphic is offset from a center of theoutlined area; capture an image of the testing device, the imageincluding a color mosaic having at least one color value correspondingto a positive test result and the test line; process the image todetermine the color values of the pixels on the test line of the atleast one immunoassay test strip; compare the color values of the imageof the test line to the color values of the image of the color mosaic;determine if the color values of the image of the test line is within apredetermined range of the at least one color value of the image of thecolor mosaic corresponding to a positive test result; and present testresults on the viewing screen.
 2. The system of claim 1 wherein thesoftware application, when executed, further causes the mobile deviceto: detect when an alignment of the outlined area and the borders of thetesting device has taken place, and when an alignment of the alignmentgraphic and the alignment target has taken place; and capture an imageof the testing device in response to the detecting step.
 3. The systemof claim 1 wherein the color values of the pixels of the image of thetest line are averaged and an average color value of the image of thetest line is compared to the color values of the image of the colormosaic.
 4. The system of claim 3 wherein the test line of one of aplurality of immunoassay test strips includes Zika virus antigens andthe test line of another one of the plurality of immunoassay test stripsincludes antibodies suitable for binding with hCG, and wherein thesoftware application, when executed, further causes the mobile deviceto: collect at least one biologic with a testing device having thereonan alignment target and contacting the test line of the one of theplurality of immunoassay test strips that includes Zika virus antigenswith the biologic; and contact the test line of the one of the pluralityof immunoassay test strips that includes antibodies suitable for bindingwith hCG.
 5. A method for providing immunoassay test results for medicalconditions, comprising: collecting at least one biologic with a testingdevice including at least one immunoassay test strip; conjugating the atleast one biologic with particles on a conjugate pad on the at least oneimmunoassay test strip to create an immune complex; receiving the immunecomplex at a test line on a membrane strip on the at least oneimmunoassay test strip, wherein the test line includes particularantigens or antibodies; binding, if the immune complex contains antigensor antibodies capable of binding with the particular antigens orantibodies included on the test line, the antigens or antibodies of theimmune complex to the antigens or antibodies of the test line; producinga qualitative response on the test line if the antigens or antibodies ofthe immune complex are bound to the antigens or antibodies on the testline; providing a software application to be stored on a mobile device,the mobile device having a camera and a viewing screen; presenting anoutlined area on the viewing screen to be aligned with borders of thetesting device; presenting on the viewing screen an alignment graphic tobe aligned with an alignment target of the testing device, wherein thealignment graphic is offset from a center of the outlined area;capturing an image of the testing device, the image including a colormosaic having at least one color value corresponding to a positive testresult and the test line; processing the image to determine the colorvalues of the pixels on the test line of the at least one immunoassaytest strip; comparing the color values of the image of the test line tothe color values of the image of the color mosaic; determining if thecolor values of the image of the test line is within a predeterminedrange of the at least one color value of the image of the color mosaiccorresponding to a positive test result; and presenting test results onthe viewing screen.
 6. The method of claim 5 further comprising:detecting when an alignment of the outlined area and the borders of thetesting device has taken place, and when an alignment of the alignmentgraphic and the alignment target has taken place; and capturing an imageof the testing device in response to the detecting step.
 7. The methodof claim 5 wherein the color values of the pixels of the image of thetest line are averaged and an average color value of the image of thetest line is compared to the color values of the image of the colormosaic.
 8. The method of claim 7 wherein the test line of one of aplurality of immunoassay test strips includes Zika virus antigens andthe test line of another one of the plurality of immunoassay test stripsincludes antibodies suitable for binding with hCG, the method furthercomprising: collecting at least one biologic with a testing devicehaving thereon an alignment target and contacting the test line of theone of the plurality of immunoassay test strips that includes Zika virusantigens with the biologic; and contacting the test line of the one ofthe plurality of immunoassay test strips that includes antibodiessuitable for binding with hCG.
 9. A method for providing immunoassaytest results for medical conditions, comprising: collecting at least onebiologic with a testing device; conjugating the at least one biologicwith particles on a conjugate pad on the at least one immunoassay teststrip to create an immune complex; receiving the immune complex at atest line on a membrane strip on the at least one immunoassay teststrip, wherein the test line includes particular antigens or antibodies;binding, if the immune complex contains antigens or antibodies capableof binding with the particular antigens or antibodies included on thetest line, the antigens or antibodies of the immune complex to theantigens or antibodies of the test line; producing a qualitativeresponse on the test line if the antigens or antibodies of the immunecomplex are bound to the antigens or antibodies on the test line;providing a software application to be stored on a mobile device, themobile device having a camera and a viewing screen; presenting anoutlined area on the viewing screen to be aligned with borders of thetesting device; presenting on the viewing screen an alignment graphic tobe aligned with an alignment target of the testing device, wherein thealignment graphic is offset from a center of the outlined area;capturing an image of the testing device, the image including a colormosaic having a plurality of different colors at different locations inthe mosaic; identifying the different colors at the different locationsin the captured image of the color mosaic; comparing the differentcolors at the different locations in the captured image of the colormosaic to known color values for the different locations in the colormosaic; determining at least one color correction factor based upon thedifference(s) between the known color values for the different locationsin the color mosaic and the colors identified in the captured image atthe corresponding locations; processing the image to determine colors ofpixels on the test line and a control line of the at least oneimmunoassay test strip; applying the at least one color correctionfactor to the pixels of the test line and control line; comparing thecorrected results of processing the image of the test line to thecontrol line for the test line of the at least one immunoassay teststrip; and presenting test results on the viewing screen.
 10. The methodof claim 9 further comprising: detecting when an alignment of theoutlined area and the borders of the testing device has taken place, andwhen an alignment of the alignment graphic and the alignment target hastaken place; and capturing an image of the testing device in response tothe detecting step.
 11. The method of claim 9 wherein the test line ofone of a plurality of immunoassay test strips includes Zika virusantigens and the test line of another one of the plurality ofimmunoassay test strips includes antibodies suitable for binding withhCG, the method further comprising: collecting at least one biologicwith a testing device having thereon an alignment target and contactingthe test line of the one of the plurality of immunoassay test stripsthat includes Zika virus antigens with the biologic; and contacting thetest line of the one of the plurality of immunoassay test strips thatincludes antibodies suitable for binding with hCG.
 12. The method ofclaim 9 further comprising transmitting the captured image of the colormosaic to a remote server and comparing, with the remote server, thedifferent colors at the different locations in the captured image of thecolor mosaic to known color values for the different locations in thecolor mosaic.